NCT00025376
PS-341 in Treating Patients With Metastatic Kidney Cancer
PHASE2
COMPLETED
NCT00025376
INTERVENTIONAL
A Phase II Trial of PS-341 in Patients With Renal Cell Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of PS-341 is more effective in treating metastatic kidney cancer.
PURPOSE: Randomized phase III trial to study the effectiveness of PS-341 in treating patients who have metastatic kidney cancer.
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed metastatic renal cell cancer
* Measurable disease
* At least 2.0 cm in at least 1 dimension by physical exam OR at least 1.0 cm in at least 1 dimension by radiologic exam
* Single measurable lesion must not be within prior radiotherapy portal
* Tumor lesion amenable to core biopsy
* At least 1 cm of tumor obtainable
* No active CNS metastatic disease
* Single previously resected CNS metastasis allowed provided no disease progression 8 weeks after therapy and no longer requiring steroids or antiseizure medications
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Not specified
Life expectancy:
* More than 3 months
Hematopoietic:
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST/ALT no greater than 2.5 times ULN
Renal:
* Creatinine no greater than 2.0 mg/dL
Cardiovascular:
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
Other:
* No other uncontrolled concurrent illness
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier-method contraception during and for 3 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Prior immunotherapy or biotherapy allowed
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* See Disease Characteristics
Radiotherapy:
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy
* No prior radiotherapy to 25% or more of bone marrow (i.e., whole pelvis)
Surgery:
* See Disease Characteristics
Other:
* No other concurrent investigational agents
* No concurrent combination antiretroviral therapy for HIV-positive patients
Kidney Cancer
- TREATMENT
-
- Type: DRUG
- Name: PS-341
- Description:
- Arm Group Labels: PS-341 administration followed by biopsy, Pre-Treatment biopsy followed by PS-341 administration
-
- Type: PROCEDURE
- Name: Tumor Biopsy
- Description:
- Arm Group Labels: PS-341 administration followed by biopsy, Pre-Treatment biopsy followed by PS-341 administration
- University of Chicago